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Results for “SERENA”
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EUDAMED
157
FDA 510(k)
9
FDA PMA
1
GUDID
138
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European Union (all)
155
United States
148
More countries (6)
France
54
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47
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33
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17
Netherlands
4
Northern Ireland
2
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Class I
268
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Class IIb
6
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6
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18
More classes (11)
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IVD Annex II List A
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IVD for self-testing
Active implantable (AIMDD)
4
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1
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304 devices found
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Device · Manufacturer · Authorizations
Verified
Status
Regime
Registry
Class
EMA Serena Patient Starter kits
Ema Sleep Incorporated
·
,
FDA registration: United States
Class II
GUDID
on market
None
GUDID
II
Serena Fixed Hinge
Serena Sleep Solutions LLC
·
,
FDA registration: United States
Class II
GUDID
on market
None
GUDID
II
Serena Sure
Serena Sleep Solutions LLC
·
,
FDA registration: United States
Class II
GUDID
on market
None
GUDID
II
Pristina Serena
Open recall
GE Healthcare
·
,
United States
Class II
FDA 510(k)
K173576
Active
Cleared 14 May 2018
Active
510(k)
510(k)
II
Serena
UDI-DI 08051881001602
Chinesport S.P.A.
·
,
Italy
Class I
CE/MDR
Active
CE MDR
EUDAMED
I
26 variants
Serena
LZ213C2W3
Serena
LZ213D1W3
Serena
LZ213D2W3
See all variants of this device
Serena
UDI-DI 03376122195342
Podowell
·
,
France
Class I
CE/MDR
Active
CE MDR
EUDAMED
I
16 variants
Serena
SERENA-0100-P35
Serena
SERENA-0100-P37
Serena
SERENA-0100-P42
Serena
SERENA-0602-P35
Serena
SERENA-0602-P37
Serena
SERENA-0602-P41
See all variants of this device
Nevio
UDI-DI 08051881027725
Chinesport S.P.A.
·
,
Italy
Class I
CE/MDR
Active
CE MDR
EUDAMED
I
14 variants
Nevio
LZ112D1W3
Nevio
LZ112D1WR
Nevio
LZ112D2W7
Nevio
LZ112D2WL
See all variants of this device
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Showing 81-100 of 304